FDA.reportPublic FDA data

NDC 57319-547 - TRI OTIC

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
57319-547
Package NDCs from labels
57319-547-64, 57319-547-63, 57319-547-65, 57319-547-71, 57319-547-67, 57319-547-68
Manufacturer
Clipper Distribution Company LLC | Med-Pharmex, Inc
Effective date
2001-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TRI OTIC - Clipper Distribution Company LLC | Med-Pharmex, IncClipper Distribution Company LLC | Med-Pharmex, Inc2001-01-01PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE VALERATEACTIVE INGREDIENT9IFA5XM7R2TRI OTIC (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE ) OINTMENT [CLIPPER DISTRIBUTION COMPANY LLC]1
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65TRI OTIC (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE ) OINTMENT [CLIPPER DISTRIBUTION COMPANY LLC]1
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVTRI OTIC (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE ) OINTMENT [CLIPPER DISTRIBUTION COMPANY LLC]1
BETAMETHASONEACTIVE MOIETY9842X06Q6MTRI OTIC (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE ) OINTMENT [CLIPPER DISTRIBUTION COMPANY LLC]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65TRI OTIC (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE ) OINTMENT [CLIPPER DISTRIBUTION COMPANY LLC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGTRI OTIC (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE ) OINTMENT [CLIPPER DISTRIBUTION COMPANY LLC]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 15 · 296 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinea Versicolor Treatment BarCLOTRIMAZOLEBeautivity LLC33612382-2f12-e9f6-e063-6394a90aaee42026-06-29WarningsExact identifier
unii: G07GZ97H65
Hermon Clotrimazole antifungal treatment creamCLOTRIMAZOLE 1%Beautivity LLC3c9bd942-49c6-cada-e063-6394a90a31662026-06-29WarningsExact identifier
unii: G07GZ97H65
Hermon Clotrimazole antifungal soap. barCLOTRIMAZOLE 1%Beautivity LLC3cdcf8cc-510c-6115-e063-6294a90ac3ea2026-06-29WarningsExact identifier
unii: G07GZ97H65
RoyceDerm Antifungal .spray.CLOTRIMAZOLE 1%RoyceDerm LLC54d3ae29-8919-4868-e063-6294a90a587e2026-06-22WarningsExact identifier
unii: G07GZ97H65
Terramed Just Think Comfort Clotrimazole Antifungal Topical SolutionCLOTRIMAZOLERida LLC83a9c5dc-c969-43a7-a763-44783710d5d02026-06-18WarningsExact identifier
unii: G07GZ97H65
Beilloso Hyaluronic AcidCLOTRIMAZOLE 1 PERCENT HYALURONIC ACIDJiangxi Yudexi Pharmaceutical Co., LTD4a712797-c992-dd8e-e063-6294a90a05922026-06-14WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEYYBA CORP53fed66b-a371-38d2-e063-6294a90a510e2026-06-11WarningsExact identifier
unii: G07GZ97H65
Velloryn 1% Clotrimazole ANTIFUNGALVELLORYN 1% CLOTRIMAZOLE ANTIFUNGALGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd540652da-f8f0-01ee-e063-6294a90a12e92026-06-11WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLERedpharm Drug53cafc9f-7761-83a9-e063-6294a90a34372026-06-09Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
Antifungal 1% Clotrimazole CreamANTIFUNGAL 1% CLOTRIMAZOLE CREAMTwincraft Inc.29698d9e-8449-ceee-e063-6394a90a366e2026-06-09WarningsExact identifier
unii: G07GZ97H65
Antifungal 1% Clotrimazole CreamANTIFUNGAL 1% CLOTRIMAZOLE CREAMDefense Soap LLC040264b2-8f2f-f059-e063-6294a90ad7202026-06-09WarningsExact identifier
unii: G07GZ97H65
BODYKOO JOCK ITCH CreamCLOTRIMAZOLE1% JOCK ITCH CREAMJiangxi Yudexi Pharmaceutical Co., LTD53553b31-81bb-d293-e063-6294a90aa0a52026-06-09WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEWalgreens7ca79361-6608-4eda-ba5b-16c28eb6c0192026-06-09WarningsExact identifier
unii: G07GZ97H65
Clotrimazole CreamCLOTRIMAZOLE USP1%Aldermed Inc.53bdd76b-6290-f1d3-e063-6394a90a9ff12026-06-08WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.13a14d3c-bfce-42b5-8463-4ec69e94774e2026-06-03WarningsExact identifier
unii: G07GZ97H65
Athletes Foot CreamCLOTRIMAZOLEShenzhen Miandou Technology Co.,Ltd.53451e74-719e-9499-e063-6394a90a9e5a2026-06-02WarningsExact identifier
unii: G07GZ97H65
RoyceDerm Tea Tree Oil Antifungal .spray.CLOTRIMAZOLE 1%RoyceDerm LLC52da8be4-467c-c011-e063-6294a90a166f2026-05-28WarningsExact identifier
unii: G07GZ97H65
Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.977180b3-a222-4282-d485-4a32176743052026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Medi-First Clotrimazole 1% ANTIFUNGAL CreamCLOTRIMAZOLEUnifirst First Aid Corporation522eeb91-8378-32f4-e063-6394a90aff432026-05-20WarningsExact identifier
unii: G07GZ97H65
Fungicure IntensiveCLOTRIMAZOLEKobayashi Healthcare International, Inc.1f1b413f-278e-434f-8590-4cf731663f5c2026-05-15WarningsExact identifier
unii: G07GZ97H65

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.